Post-Op Lidocaine Patch

NCT03500211 | Completed Phase 4 Results FDA Drug

• 1 other identifier: OHSU IRB 16657
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.

Conditions

Pain, Postoperative

Keywords

Cesarean section; Postoperative pain

Outcome Measures

Primary Outcomes (4)

• 12-hour Postoperative Pain Scores

  To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

  Postoperative (12 hours)

• 24-hour Postoperative Pain Scores

  To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

  Postoperative (24 hours)

• 36-hour Postoperative Pain Scores

  To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 36 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

  Postoperative (36 hours)

• 48-hour Postoperative Pain Scores

  To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 48 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

  Postoperative (48 hours)

Secondary Outcomes (1)

• 5-days Postoperative Narcotic Use

  Postoperative (5 days)

Study Arms (2)

Lidoderm 5% Topical Patch

EXPERIMENTAL

5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Drug: Lidoderm 5 % Topical Patch

Sham Topical Patch

SHAM COMPARATOR

Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Other: Sham Topical Patch

Interventions

Lidoderm 5 % Topical Patch DRUG

Lidocaine patch after cesarean section delivery.

Also known as: lidocaine patch

Lidoderm 5% Topical Patch

Sham Topical Patch OTHER

Sham patch after cesarean section delivery.

Also known as: sham patch

Sham Topical Patch

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant patients who require a scheduled or non-urgent cesarean birth
• Patient able to receive neuraxial analgesia
• Patient able to give verbal and written consent for both cesarean birth and study

You may not qualify if:

• Patients requiring emergent cesarean birth
• Patients allergic to lidocaine or adhesive
• Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth
• Patients using chronic oral neuromodulators
• Patients with cardiac disease or using anti-arrhythmic agents
• Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus.
• Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidoderm; Transdermal Patch

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: OB/Gyn Regulatory Specialist
• Organization: Oregon Health & Science University

whru@ohsu.edu

503-494-3666

Study Officials

• Catherine Leclair, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 18, 2018
• Study Start: March 13, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 11, 2020
• Results First Posted: March 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)